Overview; Methods - Covidien Nellcor Operator's Manual

A Clinical Studies

Overview

A.1
This appendix contains data from clinical studies conducted for the Nellcor™
sensors used with the Nellcor™ Bedside SpO
One (1) prospective, controlled hypoxia clinical study was conducted to demon-
strate the accuracy of Nellcor™ sensors when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System. The study was per-
formed with healthy volunteers at a single clinical laboratory. Accuracy was estab-
lished by comparison to CO-oximetry.

Methods

A.2
Data from 11 healthy volunteers were included in the analysis. Sensors were
rotated on digits and brow to provide a balanced study design. SpO
were continuously recorded from each instrument while inspired oxygen was
controlled to produce five steady state plateaus at target saturations of approx-
imately 98, 90, 80, 70 and 60%. Six arterial samples were taken 20 seconds
apart at each plateau resulting in a total of approximately 30 samples per sub-
ject. Each arterial sample was drawn over two (2) respiratory cycles (approxi-
mately 10 seconds) while SpO
for direct comparison to CO
of the three IL CO-oximeters and a mean SaO
End tidal CO , respiratory rate, and respiratory pattern were continuously mon-
2
itored throughout the study.
Patient Monitoring System.
2
data were simultaneously collected and marked
2
. Each arterial sample was analyzed by at least two
2
was calculated for each sample.
2
values
2
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